Thermo Fisher Scientific Inc. TMO recently gained pre-market approval from the FDA for its Oncomine Dx Target Test as a companion diagnostic (CDx) to detect patients with epidermal growth factor receptor (EGFR) Exon20 insertion mutation-positive metastatic non-small cell lung cancer (mNSCLC), who are eligible of becoming candidates for EXKIVITY (mobocertinib). The EXKIVITY, developed by Takeda Pharmaceutical Company Limited (“Takeda”), is a small-molecule tyrosine kinase inhibitor (TKI) developed to selectively target EGFR Exon20 insertion mutations.Per Thermo Fisher’s management, the recent FDA authorization of the Oncomine Dx Target Test as a CDx for EXKIVITY will enable clinicians to detect key biomarkers in patients who can potentially benefit from this targeted therapy.This authorization is likely to bolster Thermo Fisher’s CDx solutions for oncology to advance precision medicine.More About EXKIVITYIn September 2021, the FDA approved EXKIVITY for the treatment of adult patients who have locally advanced or metastatic NSCLC with EGFR Exon20 insertion mutations as identified by an FDA-approved test and whose disease has progressed on or after platinum-based chemotherapy.Image Source: Zacks Investment ResearchThis indication is approved under Accelerated Approval on the basis of an overall response rate and duration of response demonstrated in the platinum-pretreated population of the Phase 1/2 trial of EXKIVITY. In fact, continued approval for this indication could depend on the verification and description of clinical benefit in a confirmatory trial.More on the NewsTraditional polymerase chain reaction (PCR) methods can miss up to 50% of EGFR Exon20 insertion mutations. In this regard, diagnostic molecular testing using next-generation sequencing (NGS) technology becomes pertinent for early identification and proper characterization of tested patients. Notably, the Oncomine Dx Target Test is a NGS-based test, which can evaluate 23 genes associated with NSCLC at the same time.The Oncomine Dx Target Test was initially authorized as a CDx by the FDA in 2017. At present, this test is authorized for five targeted therapies for NSCLC and one targeted therapy for cholangiocarcinoma in the United States. Presently, government and commercial insurers in more than 15 countries, including the United States, several European nations, Japan, South Korea and the Middle East, have approved and reimbursed the test.Industry ProspectsPer a report published in Grand View Research, the global oncology companion diagnostic market is expected to see a CAGR of 12.7% from 2020 to 2027. Factors such as changing role of oncology CDx in the era of next-generation omics; increased adoption of oncology CDx assays by pharmaceutical manufacturers owing to their economic benefits as well as their ability to reduce clinical trial timelines; and enhanced drug and diagnostics co-development models post the issuance of the FDA’s “In Vitro Companion Diagnostic Devices” guidance in 2016 are fueling market growth.Given the substantial market prospects, the recent FDA authorization of the Oncomine Dx Target Test as a CDx for EXKIVITY seems strategic.Notable DevelopmentsThermo Fisher has been engaging in a number of significant developments this month.The company’s Oncomine Dx Target Test received approval from Japan’s Ministry of Health, Labour and Welfare (MHLW) as a NGS-based CDx intended for patients with RET-fusion positive non-small-cell lung cancer (NSCLC), who are eligible for treatment with Eli Lilly and Company's LLY selpercatinib (formerly known as LOXO-292). The Oncomine Dx Target Test has been approved in Japan as a CDx for five biomarkers with a total of 10 associated targeted therapies for NSCLC patients.Thermo Fisher’s clinical sequencing business and AstraZeneca have collaborated to co-develop NGS-based CDx to support AstraZeneca's expanding portfolio of targeted therapies. The companies collaborated under a multi-year global agreement to accelerate the development and introduction of targeted precision medicine therapies.Share Price PerformanceThe stock has outperformed its industry over the past year. It has grown 29.8% compared to the industry’s growth of 15.2%.Zacks Rank and Key PicksCurrently, Thermo Fisher carries a Zacks Rank #3 (Hold).A couple of better-ranked stocks from the Medical-Instruments industry include Semler Scientific Inc. SMLR and IDEXX Laboratories, Inc. IDXX, each carrying a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.Semler Scientific has a long-term earnings growth rate of 25%.IDEXX has a long-term earnings growth rate of 19.9%. Zacks Names "Single Best Pick to Double" From thousands of stocks, 5 Zacks experts each have chosen their favorite to skyrocket +100% or more in months to come. From those 5, Director of Research Sheraz Mian hand-picks one to have the most explosive upside of all. You know this company from its past glory days, but few would expect that it's poised for a monster turnaround. Fresh from a successful repositioning and flush with A-list celeb endorsements, it could rival or surpass other recent Zacks' Stocks Set to Double like Boston Beer Company which shot up +143.0% in a little more than 9 months and Nvidia which boomed +175.9% in one year.Free: See Our Top Stock and 4 Runners Up >>Want the latest recommendations from Zacks Investment Research? Today, you can download 7 Best Stocks for the Next 30 Days. Click to get this free report Eli Lilly and Company (LLY): Free Stock Analysis Report Thermo Fisher Scientific Inc. (TMO): Free Stock Analysis Report IDEXX Laboratories, Inc. (IDXX): Free Stock Analysis Report Semler Scientific Inc. (SMLR): Free Stock Analysis Report To read this article on Zacks.com click here.